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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Sky Medical a.s.

Certificate ITH 1450762 1

Rev. 2.0Supplemented
Valid until
Nov 22, 2027

Overview

Certificate number
ITH 1450762 1
Certificate type
Quality management system
Certificate status
Supplemented
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
2
Certificate ID
1936ITH 1450762 12.0

Validity

Issued
Jun 6, 2024
Valid from
Jun 6, 2024
Valid until
Nov 22, 2027

Manufacturer

Manufacturer
Sky Medical a.s.
Manufacturer SRN
SK-MF-000001475
Manufacturer country
Slovakia

Notified body

Notified body
TUV Rheinland Italia SRL
Notified body SRN
1936
Notified body country
Italy

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile
Yes
Human tissues
No
Animal tissues
No
In vitro diagnostics
No
Initial registration
No
New device
No
Discard allowed
No
SSCP enabled
Yes
Mechanism of scrutiny
Yes
Intended medical purpose
No
SPP applicable
No
Conditions applicable
Yes
MOS outside EUDAMED
—
QMS/MOS type
Class IIb only

History

Status changes

  • Supplemented

Supersedes

  • ITH 1450762 1Quality management systemIssuedSep 11, 2023 → Nov 22, 2027

Scope coverage

Class IIb1

1 scope

  • Dispositivi non attivi non impiantabili per la somministrazione, la canalizzazione e la rimozione di sostanze, compresi i dispositivi per la dialisi / Non-active non-implantable devices for administration, channeling and removal of substances, including devices for dialysis
    Class IIb

Documents

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